P2, N=23, Completed, Dana-Farber Cancer Institute | Active, not recruiting --> Completed

P3, N=246, Active, not recruiting, R-Pharm

In a human PBMC-engrafted NSG mouse xenograft lung cancer model, an anti-HER2 × anti-NKG2A BiNK markedly inhibited tumor growth as a monotherapy or in combination with pertuzumab. Cell depletion studies revealed that the BiNK enhanced antitumor activity of both NK and T cells. NKG2A blockade with potent and specific, fully human antibodies and BiNKs show promise for further development as cancer immunotherapeutics.

P=N/A, N=60, Not yet recruiting, The First Affiliated Hospital of Guangzhou Medical University

P4, N=84, Not yet recruiting, Qilu Hospital of Shandong University; Qilu Hospital of Shandong University

P4, N=188, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital; Tianjin Medical University Cancer Institute and Hospital

The study was developed at the Cancer Institute of the State of São Paulo (ICESP) according to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommendations.ResultsIt was possible to obtain a ranking of the 8 alternatives: the first, second and third position were respectively: neoadjuvant treatment without anthracycline and anti-HER2 therapy with only trastuzumab followed by adjuvant trastuzumab (global value 0.739); neoadjuvant treatment with anthracycline and anti-HER2 trastuzumab alone followed by adjuvant trastuzumab (global value 0.717) and neoadjuvant treament with anthracycline plus trastuzumab alone or double anti-HER2 blockade with trastuzumab and pertuzumab, followed by adjuvant T-DM1 (global value 0.697). The criteria that received the greatest weight from stakeholders were in descending order: disease-free survival, cost, severity of the disease, adverse reactions and overall survival.ConclusionMCDA made it possible to compare treatment alternatives for non-metastatic, HER2+, HR + breast cancer, with the most innovative technology T-DM1 appearing fourth.

CTR20212874. Registration date: 3 September 2021.

This retrospective analysis suggests that using a slow bolus injection with an infusion pump may reduce local adverse reactions following subcutaneous administration of pertuzumab and trastuzumab in patients with HER2-positive breast cancer. The standardized use of infusion pumps could enhance patient comfort, safety, and overall treatment experience.

Trastuzumab, the first humanized monoclonal antibody targeting the extracellular domain of HER2, improves both pCR and event-free survival when added to standard regimens. Pertuzumab, which binds to domain II of HER2 and inhibits HER2-HER3 dimerization, provides complementary activity...However, emerging predictive biomarkers are currently under investigation to further optimize escalation and de-escalation treatment strategies. Future studies on larger cohorts incorporating these additional biomarkers are needed to enhance predictive models and guide personalized therapy.

Trastuzumab CT-P6 combined with pertuzumab and chemotherapy can be used in neoadjuvant treatment for HER2-positive early breast cancer, showing pCR rates comparable to the reference trastuzumab and without evidence of immunogenicity. Exploratory analyses of soluble HER2 and anti-trastuzumab CT-P6 antibodies did not demonstrate a significant association with pCR, although this possibility cannot be excluded. Their assessment contributes to the translational understanding of biosimilar integration into curative regimens.